Listen, and understand. That pharmacy is out there. It can't be bargained with. It can't be reasoned with. It doesn't feel pity, or remorse, or fear. And it absolutely will not stop, ever, until you are dead

The quarterly projections didn't provide the anticipated revenue to comply with the burdensome sterilization regulations and meet contractually required executive retention payments during the same expenditure cycle.

You sir are a team player, and obviously think outside the box. If you can include a Pareto chart or two within your presentation I believe we will have a win win for corporate!

As someone who had a 4cm3 tumor removed from my brain shortly after this story broke and was going on a regiment of injected steroids to keep brain swelling at a minimum, I was really freaked the fark out and asked anyone and everyone each time I was due for an injection who the steroid manufacturer was, until the charge nurse came in and told me they have never used that company.

If I killed 32 people, via negligence (or perhaps *willful negligence*), I would

A) Be facing a shiat-ton of manslaughter charges AT THE VERY LEAST, or perhaps even negligent homicide, or even murder.

B) I would not be able to use the defense of "Oh, honestly, your honor, my brain didn't know what my hand was doing. My hand acted independently of the wishes of myself and I bear no responsibility for its actions. (Because, I would think, the CEO of a company is analogous to the brain/mind. Otherwise, WTF are they paid for?)

The 5th Amendment doesn't apply to CIVIL matters, of getting sued. It's only for criminal cases, where you'd actual jail is on the table for you. Personally. Not "someone in your company", you can't plead the 5th to protect ANYONE ELSE.

If I killed 32 people, via negligence (or perhaps *willful negligence*), I would

A) Be facing a shiat-ton of manslaughter charges AT THE VERY LEAST, or perhaps even negligent homicide, or even murder.

B) I would not be able to use the defense of "Oh, honestly, your honor, my brain didn't know what my hand was doing. My hand acted independently of the wishes of myself and I bear no responsibility for its actions. (Because, I would think, the CEO of a company is analogous to the brain/mind. Otherwise, WTF are they paid for?)

The 5th Amendment doesn't apply to CIVIL matters, of getting sued. It's only for criminal cases, where you'd actual jail is on the table for you. Personally. Not "someone in your company", you can't plead the 5th to protect ANYONE ELSE.

The human principals of the company may face criminal charges. They have already lost their professional licenses and been named in civil suits. In highly regulated fields like engineering and medicine a company's operations must be supervised by a license holder. The licensed pharmacists had a duty to see that proper standards were complied with, unlike the CEO of a tech company who can plead ignorance and designate a fall guy.

Tron: There are! I say there are so many amendments in the constitution of the United States of Americaaaa! I can only choose one! I can only choose ooooooone! I plead the fif! I plead the fif! FIVE! 1,2,3,4, fiiiif! Anything you say! FIIIF! Go ahead and ask me a question!

If I killed 32 people, via negligence (or perhaps *willful negligence*), I would

A) Be facing a shiat-ton of manslaughter charges AT THE VERY LEAST, or perhaps even negligent homicide, or even murder.

B) I would not be able to use the defense of "Oh, honestly, your honor, my brain didn't know what my hand was doing. My hand acted independently of the wishes of myself and I bear no responsibility for its actions. (Because, I would think, the CEO of a company is analogous to the brain/mind. Otherwise, WTF are they paid for?)

The 5th Amendment doesn't apply to CIVIL matters, of getting sued. It's only for criminal cases, where you'd actual jail is on the table for you. Personally. Not "someone in your company", you can't plead the 5th to protect ANYONE ELSE.

Yes, but I would also still, you know, probably already have been arrested if I did that.

buckler:BronyMedic: Jument: That's pretty scary. Can someone please explain how they ended up making drugs somehow tainted with "fungal meningitis"?

Poor sterile practice.

Does that stuff just drop from the air, or what?

You know that garbage stink you smell at a bottle return (if your state does that)? That same junk and worse came into the facility through the air, people's clothes, etc. This was a family business that shared employees with the other family business, garbage recycling.

UsikFark:You know that garbage stink you smell at a bottle return (if your state does that)? That same junk and worse came into the facility through the air, people's clothes, etc. This was a family business that shared employees with the other family business, garbage recycling.

Please, please, please tell me that you are joking. Tell me that this is not true, and tell me in a way that I can believe you, so that I can sleep tonight.

Jument:That's pretty scary. Can someone please explain how they ended up making drugs somehow tainted with "fungal meningitis"?

Sloppy lab practices. All that needs to have happened is for the contaminant to have entered the processing equipment for one batch (or two, I don't know exactly how the process works). And poor quality control. They should have been pulling and testing a random 10% of all final products and obviously were not.

Some of it can be thrown off on the state inspectors, of course, who should also have been doing testing; but I'm not about to let the private business get away with that. You can't demand less regulation and then hide behind those same regs when you get caught with dirty equipment.

Jument:That's pretty scary. Can someone please explain how they ended up making drugs somehow tainted with "fungal meningitis"?

Haven't read this whole thread, so forgive me if this already been cleared up.My hospital purchased drugs from them up until this happened, so we've sort of been following it closely. My understanding of it was that the compounding rooms, which are supposed to be sterile obviously, were not being air conditioned when the place was closed for the evenings.

The human principals of the company may face criminal charges. They have already lost their professional licenses and been named in civil suits. In highly regulated fields like engineering and medicine a company's operations must be supervised by a license holder. The licensed pharmacists had a duty to see that proper standards were complied with, unlike the CEO of a tech company who can plead ignorance and designate a fall guy.

Congressional testimony rules are "weird". I mean they lack the rules, defined purpose, and privacy of a court hearing. And it's on the Legislative branch, not Judicial, which is a wildly different context. There's a shiatton of rules on what a prosecutor can ask, and the prosecutor's a career professional at this specific job. This is just empowered Legislators with little professional obligation, control, or rules.

Often grandstanding with a biased, openly accusatory speech for the cameras, and the actual question is lost. Then the questioner covers at the end with "what do you have to say about that?" to TECHNICALLY make a question out of it. Of course once you've framed a question like "What we want to know is, did you plan to kill people INTENTIONALLY, or were you simply grossly negligent?" it's kinda hard to answer. You wouldn't find that sort of manipulative leading question in a civil or criminal court, the defense would object and the judge won't allow it. But no judge presides over this to maintain a modicum of fair procedure.

The Larch:UsikFark: You know that garbage stink you smell at a bottle return (if your state does that)? That same junk and worse came into the facility through the air, people's clothes, etc. This was a family business that shared employees with the other family business, garbage recycling.

Please, please, please tell me that you are joking. Tell me that this is not true, and tell me in a way that I can believe you, so that I can sleep tonight.

Because we are a corporation and we can. Once again, another miracle of science -- painful death -- brought to us by the magic of the market place and the millionaire "job creators" we should continue rewarding with tax breaks.

Bendal:Jument: That's pretty scary. Can someone please explain how they ended up making drugs somehow tainted with "fungal meningitis"?

I'm sure Obama's "job killing regulations" are behind all this. You know, those regulations Romney vowed to repeal so "job creators" could get busy making jobs? It was probably one of those that put that fungus in the drugs.

/that, or the cost cutting, penny pinching attitude that most corporations have when there isn't a regulation making them do something

My father in law is somewhat centre-right for Canada. But he has a really sensible idea about this "Companies want to make as much money as possible, governments need to regulate things so partnering companies are making the most money when they do what the government wants them to."

The Larch:UsikFark: You know that garbage stink you smell at a bottle return (if your state does that)? That same junk and worse came into the facility through the air, people's clothes, etc. This was a family business that shared employees with the other family business, garbage recycling.

Please, please, please tell me that you are joking. Tell me that this is not true, and tell me in a way that I can believe you, so that I can sleep tonight.

Also, here is another picture:

HERE is an elaboration on my "family business" point, so you know I'm not full of shiat.

You sir just blew my mind. As a lab manager in the Boston/Cambridge area I've used Conigliaro in the past. If I remember correctly they're one of the only places that will take styrofoam for recycling. I had no idea they were connected to this. Building a new facility and will not be using them for my recycling anymore.

Remember, it's not just the poor sterilization. From what I understand, as a compounding pharmacy they weren't supposed to be creating large batches of ANYTHING for sale on the mass market. They were supposed to only be filling existing, specific prescriptions.

I see people speaking as if this were some massive pharmaceutical company. It's not. It's basically a glorified warehouse located in a relatively small business park, for God's sake. They had NO business selling what they were selling. I just wonder how long they were able to get away with it before the obvious happened.

ZAZ:The human principals of the company may face criminal charges. They have already lost their professional licenses and been named in civil suits. In highly regulated fields like engineering and medicine a company's operations must be supervised by a license holder. The licensed pharmacists had a duty to see that proper standards were complied with, unlike the CEO of a tech company who can plead ignorance and designate a fall guy.

Okay. That makes me feel better. Sorry, just.. so many cases out there (like the whole Union Carbide incident) where higher-ups hide behind corporate structure to escape actually paying a pentalty (or only paying a monetary one) for, among other things, causing the deaths of people.

Prospero424:Remember, it's not just the poor sterilization. From what I understand, as a compounding pharmacy they weren't supposed to be creating large batches of ANYTHING for sale on the mass market. They were supposed to only be filling existing, specific prescriptions.

I see people speaking as if this were some massive pharmaceutical company. It's not. It's basically a glorified warehouse located in a relatively small business park, for God's sake. They had NO business selling what they were selling. I just wonder how long they were able to get away with it before the obvious happened.

From what I understand, there were several complaints about their products prior to this whole fiasco. The problem is the Mass Board of Pharmacy chose not to do anything about the complaints. I hear people are being fired for it now though.

wholedamnshow:Prospero424: Remember, it's not just the poor sterilization. From what I understand, as a compounding pharmacy they weren't supposed to be creating large batches of ANYTHING for sale on the mass market. They were supposed to only be filling existing, specific prescriptions.

I see people speaking as if this were some massive pharmaceutical company. It's not. It's basically a glorified warehouse located in a relatively small business park, for God's sake. They had NO business selling what they were selling. I just wonder how long they were able to get away with it before the obvious happened.

From what I understand, there were several complaints about their products prior to this whole fiasco. The problem is the Mass Board of Pharmacy chose not to do anything about the complaints. I hear people are being fired for it now though.

Wait, when did those complaints come in? I vaguely recall hearing something about Mitt Romney being connected with this company, but that may very well have been complete bullcrap, given everything that was flying around during the election.

Lawmakers probing the U.S. meningitis outbreak are focusing on why the pharmacy linked to this year's infections didn't receive greater scrutiny when potential regulatory violations were found six years ago.

The House Energy and Commerce Committee sent a letter yesterday to Margaret Hamburg, the commissioner of the Food and Drug Administration, asking her about inspections at New England Compounding Center dating to 2004. The committee cited an FDA warning in 2006 of "potential microbial contamination" and asked the agency to document what follow-up occurred.

Bendal:I'm sure Obama's "job killing regulations" are behind all this. You know, those regulations Romney vowed to repeal so "job creators" could get busy making jobs? It was probably one of those that put that fungus in the drugs.

/that, or the cost cutting, penny pinching attitude that most corporations have when there isn't a regulation making them do something

"Big questions have been raised about oversight from both state and federal regulators who repeatedly found problems at the pharmacy but did little about them."

Clearly we need new regulators to regulate the regulators and ensure that they regulate what they are supposed to be regulating. As an extra safety step, we should also add regulator regulator regulators, whose job would be to regulate the regulator regulators.

wholedamnshow:Jument: That's pretty scary. Can someone please explain how they ended up making drugs somehow tainted with "fungal meningitis"?

Haven't read this whole thread, so forgive me if this already been cleared up.My hospital purchased drugs from them up until this happened, so we've sort of been following it closely. My understanding of it was that the compounding rooms, which are supposed to be sterile obviously, were not being air conditioned when the place was closed for the evenings.

Prospero424:Remember, it's not just the poor sterilization. From what I understand, as a compounding pharmacy they weren't supposed to be creating large batches of ANYTHING for sale on the mass market. They were supposed to only be filling existing, specific prescriptions.

Correct. A compounding pharmacy should have prescriptions for every drop of medication that leaves the pharmacy. No "For office use".

I do very little sterile compounding, usually only high strength ophthalmic antibiotics.

If you do not have a rx for each drop of medication that leaves the store, you are then a manufacturer, and have to play by a whole different set of rules. Pharmacies are regulated by each individual state, manufactures are regulated by the feds.

There are even some who say compounded prescriptions should not be sold across state lines due to federal regulation of interstate commerce.

I fear the federal government is now going to try to regulate compounding pharmacies due to this major clusterfark.

You sir just blew my mind. As a lab manager in the Boston/Cambridge area I've used Conigliaro in the past. If I remember correctly they're one of the only places that will take styrofoam for recycling. I had no idea they were connected to this. Building a new facility and will not be using them for my recycling anymore.

Broktun:Prospero424: Remember, it's not just the poor sterilization. From what I understand, as a compounding pharmacy they weren't supposed to be creating large batches of ANYTHING for sale on the mass market. They were supposed to only be filling existing, specific prescriptions.

Correct. A compounding pharmacy should have prescriptions for every drop of medication that leaves the pharmacy. No "For office use".

I do very little sterile compounding, usually only high strength ophthalmic antibiotics.

If you do not have a rx for each drop of medication that leaves the store, you are then a manufacturer, and have to play by a whole different set of rules. Pharmacies are regulated by each individual state, manufactures are regulated by the feds.

There are even some who say compounded prescriptions should not be sold across state lines due to federal regulation of interstate commerce.

I fear the federal government is now going to try to regulate compounding pharmacies due to this major clusterfark.

One of my professors discussed this in class at length about 2 months before it happened. Apparently there are a number of these psuedofacturures who claim to be compounding but are really doing manufacturing. He posited that we would see a tragedy out of one of them and an reactant move by congress to change what could actually be compounded. It is interesting to see him vindicated, but wholly crap!. I can't even imagine what there processes were like based on the descriptions.Hopefully true compounding will not be impacted, just those like these dudes who were manufacturing illegally and hiding behind the compounding associations skirts.